Commonly used brand name(s)

Uses For This Medicine

In November 2000, the Food and Drug Administration (FDA) issued a public health warning regarding phenylpropanolamine (PPA) due to the risk of hemorrhagic stroke. The FDA, supported by results of a research program, requested that manufacturers voluntarily discontinue marketing products that contain PPA and that consumers work with their healthcare providers to select alternative products.

Antihistamine, decongestant, and anticholinergic combinations are used to treat the nasal congestion (stuffy nose) and runny nose caused by allergies and/or the common cold.

Antihistamines work by preventing the effects of a substance called histamine, which is produced by the body. Histamine can cause itching, sneezing, runny nose, and watery eyes. The antihistamine contained in these combinations is chlorpheniramine.

The decongestants in these combinations, phenylephrine, and pseudoephedrine produce a narrowing of blood vessels. This leads to clearing of nasal congestion, but it may also cause an increase in blood pressure in patients who have high blood pressure.

Anticholinergics, such as atropine, hyoscyamine, methscopolamine, and scopolamine may help produce a drying effect in the nose and chest.

Some of these medicines are available without a prescription.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Before Using This Medicine

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Very young children are usually more sensitive than adults to the effects of this medicine. Increases in blood pressure, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in children. Also, when anticholinergics are given to children during hot weather, a rapid increase in body temperature may occur, which may lead to heat stroke. In infants and children, especially those with spastic paralysis or brain damage, this medicine may be especially likely to cause severe side effects.

Do not give any over-the-counter (OTC) cough and cold medicine to a baby or child under 4 years of age. Using these medicines in very young children might cause serious or possibly life-threatening side effects .

Geriatric

Confusion or memory loss, difficult and painful urination, dizziness, drowsiness, dryness of mouth, or convulsions (seizures) may be more likely to occur in the elderly, who are usually more sensitive than younger adults to the effects of this medicine. Also, nightmares or unusual excitement, nervousness, restlessness, or irritability may be more likely to occur in elderly patients. In addition, eye pain may occur, which may be a sign of glaucoma.

Pregnancy

For the individual ingredients of these combinations, the following apply:

Antihistamines—Antihistamines have not been shown to cause problems in humans.

Atropine—Studies on effects in pregnancy have not been done in humans. Atropine has not been shown to cause birth defects or other problems in animals.

Hyoscyamine—Studies on effects in pregnancy have not been done in either humans or animals.

Methscopolamine—Studies on effects in pregnancy have not been done in either humans or animals.

Phenylephrine—Studies on birth defects have not been done in either humans or animals.

Pseudoephedrine—Studies on birth defects have not been done in humans. Pseudoephedrine has not been shown to cause birth defects in animal studies. However, studies in animals have shown that pseudoephedrine causes a reduction in average weight, length, and rate of bone formation in the animal fetus.

Scopolamine—Studies on effects in pregnancy have not been done in pregnant women. However, studies in animals at doses many times the human dose have shown that scopolamine causes a small increase in the number of fetal deaths.

Breast Feeding

Small amounts of antihistamines, decongestants, and anticholinergics may pass into the breast milk. Use is not recommended since this medicine may cause side effects, such as unusual excitement or irritability, in the nursing baby. Also, since this medicine tends to decrease the secretions of the body, it is possible that the flow of breast milk may be reduced in some women.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking any of these medicines, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using medicines in this class with any of the following medicines is not recommended. Your doctor may decide not to treat you with a medication in this class or change some of the other medicines you take.

Potassium

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

Brain damage in children or

Down syndrome or

Dryness of mouth (severe and continuing) or

Enlarged prostate or

Fever or

Glaucoma or

Intestinal blockage or other intestinal problems or

Kidney disease or

Liver disease or

Lung disease or

Mental or emotional problems or

Myasthenia gravis or

Toxemia of pregnancy or

Urinary tract blockage or difficult urination—These medicines may make these conditions worse.

Type 2 diabetes mellitus—The decongestant in this medicine may put diabetic patients at greater risk of having heart or blood vessel disease.

Heart or blood vessel disease or

High blood pressure—The decongestant and anticholinergic in this medicine may cause the blood pressure to increase and may also speed up the heart rate.

Overactive thyroid—If the overactive thyroid has caused a fast heartbeat, the decongestant and anticholinergic in this medicine may cause the heart rate to speed up further.

Proper Use of This Medicine

Take this medicine only as directed. Do not take more of it and do not take it more often than recommended on the label, unless otherwise directed by your doctor. To do so may increase the chance of side effects.

If this medicine irritates your stomach, you may take it with food or a glass of water or milk, to lessen the irritation.

For patients taking the extended-release capsule or extended-release tablet form of this medicine:

Swallow the capsule or tablet whole.

Do not crush, break, or chew before swallowing.

If the capsule is too large to swallow, you may mix the contents of the capsule with applesauce, jelly, honey, or syrup and swallow without chewing.

Dosing

The dose medicines in this class will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of these medicines. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Adults and children 12 years of age and older—1 or 2 tablets or chewable tablets, or 1 to 2 teaspoonfuls of syrup every four to six hours.

Children 6 to 12 years of age—1 chewable tablet or 1 teaspoonful of syrup every four hours.

Children 4 to 6 years of age—Use and dose must be determined by your doctor.

Children and infants up to 4 years of age—Use is not recommended .

For long-acting dosage forms (extended-release capsules or tablets):

For allergy and cold symptoms:

Adults and children 12 years of age and older—1 capsule or tablet every twelve hours.

Children 4 to 12 years of age—Use and dose must be determined by your doctor.

Children and infants up to 4 years of age—Use is not recommended .

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Keep out of the reach of children.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine

Check with your doctor if your symptoms do not improve or become worse, or if you have a high fever

Before you have any skin tests for allergies, tell the doctor in charge that you are taking this medicine. The results of the test may be affected by the antihistamine in this medicine.

These medicines may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke. Also hot baths or saunas may make you dizzy or faint while you are taking this medicine.

The anticholinergic contained in this medicine may cause some people to have blurred vision. Make sure your vision is clear before you drive or do anything else that could be dangerous if you are not able to see well. These medicines may also cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses may help lessen the discomfort from bright light.

These medicines may cause some people to become dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert.

The decongestant in this medicine may cause some people to be nervous or restless or to have trouble in sleeping. If you have trouble in sleeping, take the last dose of this medicine for each day a few hours before bedtime. If you have any questions about this, check with your doctor.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

This medicine may cause dryness of the mouth, nose, and throat. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

If you think you or someone else may have taken an overdose, get emergency help at once. Taking an overdose of this medicine or taking this medicine with alcohol or other CNS depressants may lead to unconsciousness and possibly death.

Side Effects of This Medicine

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Get emergency help immediately if any of the following symptoms of overdose occur:

For pseudoephedrine only

Unusual nervousness, restlessness, or excitement

Clumsiness or unsteadiness

convulsions (seizures)

drowsiness (severe)

dryness of mouth, nose, or throat (severe)

fast heartbeat

flushing or redness of face

hallucinations (seeing, hearing, or feeling things that are not there)

headache (continuing)

shortness of breath or troubled breathing

trouble in sleeping

Check with your doctor as soon as possible if any of the following side effects occur:

Rare

Irregular or slow heartbeat

mood or mental changes

skin rash, hives, or itching

sore throat and fever

tightness in chest

unusual bleeding or bruising

unusual tiredness or weakness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Drowsiness

nervousness

restlessness

thickening of mucus

trouble in sleeping

Less common - more common with high doses

Blurred vision

confusion

difficult or painful urination

dizziness

dryness of mouth, nose, or throat

fast or pounding heartbeat

headache

increased sweating

loss of appetite

nausea or vomiting

nightmares

ringing or buzzing in ears

trembling

unusual excitement, nervousness, restlessness, or irritability

unusual paleness

weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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